Valery 2010.

Methods	A multi‐centre randomised controlled trial to assess the outcomes of an education intervention for childhood asthma conducted by Australian Indigenous Health Care Workers (ICHWs).
Participants	Inclusion criteria: Indigenous children (Aboriginal or Torres Strait Islander) aged < 18 years from Thursday Island and Horn Island with a provisional diagnosis of asthma or had been referred by Indigenous healthcare workers for assessment with respiratory specialist were eligible. Exclusion criteria: Not stated Clinical asthma was defined as repeated episodes of wheeze with dyspnoea that responded to bronchodilators (in children aged 3‐6 years, 2 or more episodes of wheezy illness associated with cough and shortness of breath and documented amelioration of symptoms and clinical signs after administration of a bronchodilator). Severity of asthma was classified as persistent, frequent episodic, or infrequent episodic, based on the clinical pattern in the last 12 months. Number screened for asthma: n = 484 Number with physician confirmed asthma: n = 117 Number refused: n = 4 Number randomised: Total n = 113 (Intervention group: n = 42 and Control group: n = 71)
Interventions	Prior to the RCT, 67 ICHWs were trained in 7 separate 3‐day asthma education workshops on Thursday Island during 2005 and 2008. ICHWs also attended respiratory specialist clinics where asthma management knowledge and skills were reinforced. Existing paediatric asthma and respiratory education resources were adapted to support Torres Strait culture, including child‐friendly and age‐specific asthma booklets. Participant recruitment dates: April 2005 to March 2007 Sample Size: n = 54 children per arm After children (n = 484) were screened by the respiratory physician, those with a confirmed diagnosis of asthma (n = 117) received an education session delivered by trained ICHWs, using existing paediatric asthma and respiratory education resources which were adapted to support Torres Strait culture. Training included using a child‐friendly age‐specific asthma booklet at enrolment (prior to randomisation). Eligibility for the RCT was subsequently confirmed and consented children (n = 113) were then randomised to the intervention or control group. Intervention group: Children received additional education sessions delivered by ICHWs at 1, 3 and 6 months after the baseline visit (randomisation). Children were also clinically assessed by the ICHWs at baseline, 1,3, 6 and 12 months to collect primary and secondary outcome data. Control group: Control group children did not receive any further education sessions. Children were clinically assessed by ICHWs at the baseline visit (randomisation) and again 12 months later.
Outcomes	Primary outcome: Number of unscheduled visits to hospital or a doctor due to asthma exacerbation in 12 months after follow‐up Secondary outcomes: QoL Functional severity index for asthma Asthma knowledge and use of AAP School days missed because of wheezing Data for primary outcome were collected 12 months prior and 12 months post intervention. Data for secondary outcomes were collected as baseline (randomisation) 1, 3, 6 and 12 months
Notes	Lost to follow‐up at final assessment: n = 19. A further five children who were infrequent episodic asthmatics were excluded as study investigators could not justify the cost of transport from a remote island for the clinical assessment at 12 months. Funding: National Health and Medical Research Council, Rural Health Suport, Education and Training grant, Telstra Foundation and Royal Children's Hospital Foundation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A randomly generated list (using a computer‐generated permuted block design) stratified by age
Allocation concealment (selection bias)	Low risk	Allocation to intervention groups was revealed after enrolment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Study was unblinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unblinded study, but staff collecting data from medical records were blinded to intervention study allocation
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Five participants who had infrequent data were excluded from the 12 month follow‐up, as investigators decided it was not cost‐effective to fly participants in for this review
Selective reporting (reporting bias)	Low risk	Progress of all randomly assignment participants was clearly described. Participants analysed using a per protocol analysis (n = 88)
Other bias	Unclear risk	Nil

AAP: asthma action plan
 RCT: randomised controlled trial:
 QoL; quality of life